Situation
A client with a new adjuvant therapy for early prostate cancer (EPC) faced the need to generate economic support for the drug's anticipated budgetary impact after launch in a European market.
The clinical benefits were proven, but the regulatory dossier required solid evidence of the drug's cost-effectiveness in relation to standard care, as well as its likely impact on payer budgets. Detailed outcomes information would be essential to ensure a successful reimbursement application.
IMS Approach
IMS Oncology experts set out to model its impact within the context of current adjuvant EPC therapy and its associated costs, across a five year period.
Applying their analytical skills and modeling techniques, the team simulated the natural history of EPC and its management, comparing the drug in addition to standard care versus standard care alone.
The process involved a detailed analysis of clinical and local cost information around the treatment of EPC, including follow-up care, the management of adverse events, and transition to subsequent states of the disease. A multi center, retrospective patient chart analysis was key to establishing accurate data inputs on the mean annual costs of metastatic progression and quality adjusted life year (QALY) values for different states of the disease.
Outcome
Based on the detailed scenario modeling, which included an in-depth sensitivity analysis, IMS Oncology experts were able to identify significant quality of life benefits associated with use of the drug, in addition to its benefits in reducing the risk of objective disease progression. Compared to other treatment interventions its adjuvant use represented a cost-effective option for EPC. The client achieved reimbursement without any additional questions from the authorities relating to the health economic file.